FDA.reportPublic FDA data

AMT Mini™ Extension Set

Primary DI
00842071108120
Brand
AMT Mini™ Extension Set
Company
APPLIED MEDICAL TECHNOLOGY, INC.
Model
E6-1211-ISOSAF
Catalog number
E6-1211-ISOSAF, 6-1211-ISOSAF
Device description
12" Bolus Feeding Set with ENFit ® and Cap (Pouched)
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNTTubes, Gastrointestinal (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110804000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110804000AMT G-J TUBEApplied Medical Technology, Inc.2011-10-19KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842071108120PackageGS110In Commercial Distribution
00842071107024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842071108120008420711081208420711081200842071108120
00842071107024008420711070248420711070240842071107024

GMDN Terms#

Term, Definition table
TermDefinition
Enteral feeding/medication connector, non-sterileA non-sterile adaptor intended to enable connection of components of an enteral feeding and/or enteral medication administration kit (e.g., connection between tubing and syringe). It is typically a small plastic device containing a lumen to facilitate enteral administration after connection; it has no additional functionality and is dedicated to enteral administration applications. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length12Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(440) 717-4000cs@appliedmedical.net

Regulatory Flags#

DUNS number
038101861
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842071146290MINI Balloon Button5-14605-14602026-09-29
00842071146306MINI Balloon Button5-1460-I5-1460-I2026-09-29
00842071146313MINI Balloon Button5-14655-14652026-09-29
00842071146320MINI Balloon Button5-1465-I5-1465-I2026-09-29
00842071146351MINI Balloon Button5-16125-16122026-09-29
00842071146368MINI Balloon Button5-1612-I5-1612-I2026-09-29
00842071146399MINI Balloon Button5-16175-16172026-09-29
00842071146405MINI Balloon Button5-1617-I5-1617-I2026-09-29
00842071146450MINI Balloon Button5-16255-16252026-09-29
00842071146467MINI Balloon Button5-1625-I5-1625-I2026-09-29
00842071146511MINI Balloon Button5-16355-16352026-09-29
00842071146528MINI Balloon Button5-1635-I5-1635-I2026-09-29
00842071146559MINI Balloon Button5-16445-16442026-09-29
00842071146566MINI Balloon Button5-1644-I5-1644-I2026-09-29
00842071146597MINI Balloon Button5-18125-18122026-09-29
00842071146603MINI Balloon Button5-1812-I5-1812-I2026-09-29
00842071146436MINI Balloon Button5-16235-16232026-07-17
00842071146443MINI Balloon Button5-1623-I5-1623-I2026-07-17
00842071153083NutraGlide Nasal Feeding TubeENFT-05055-IENFT-05055-I, NFT-05055-I2026-06-10
00842071153106NutraGlide Nasal Feeding TubeENFT-05090-IENFT-05090-I, NFT-05090-I2026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00350770005881CORTRAK* 2 Enteral Access SystemAvanos Medical, Inc.KNT2026-09-30
00350770007915CORTRAK* 2 Enteral Access SystemAvanos Medical, Inc.KNT2026-09-30
00842071146290MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146306MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146313MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146320MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146351MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146368MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146399MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146405MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146450MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146467MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146511MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146528MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146559MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146566MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146597MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146603MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
G461CEGCT40M0EndolumikEndolumik, Inc.KNT2026-08-25
00350770006840CORTRAK* Enteral Access SystemAvanos Medical, Inc.KNT2026-08-21
00350770007922CORTRAK* Enteral Access System - Reusable CableAvanos Medical, Inc.KNT2026-08-21
00350770009094CORTRAK* Enteral Access SystemAvanos Medical, Inc.KNT2026-08-21
00350770009117CORTRAK* Enteral Access System - Reusable CableAvanos Medical, Inc.KNT2026-08-21
00350770007557CORFLO* Safety PEG KitAvanos Medical, Inc.KNT2026-08-14
00842071146436MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-07-17
00842071146443MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-07-17
00842071153083NutraGlide Nasal Feeding TubeAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-06-10
00842071153106NutraGlide Nasal Feeding TubeAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-06-10
00842071153120NutraGlide Nasal Feeding TubeAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-06-10
00816340021632EL-SPIKE-MNEODEVICES INCKNT2026-06-01